FDA clears Beta Bionics' Mint ACE Pump, a patch insulin pump

On September 11, 2026, the FDA cleared the Mint ACE Pump from Beta Bionics, finding it substantially equivalent to a device already on the market.[1] Beta Bionics announced the clearance on September 14 and described Mint as a patch pump with a reusable part and a disposable part, and said it does not require recharging.[2]

What the FDA cleared

The clearance, numbered K260001, came through the 510(k) pathway.[1] The FDA received the submission on January 2, 2026, and recorded its decision as "Substantially Equivalent."[3] The letter places the pump in Class II as an alternate controller enabled infusion pump, or ACE pump: an insulin pump built to take commands from compatible connected devices, including automated insulin dosing software.[1] The predicate device named in the summary is Insulet's Omnipod 5 ACE Pump.[1]

The cleared indications are narrow and specific. The pump delivers insulin under the skin for people with diabetes who need insulin, for people 6 years of age or older, for single-person home use, and it requires a prescription.[1] The summary describes the full Mint System as the pump with Beta Bionics' iLet Dosing Decision Software preinstalled, Mint cartridges, a CGM and the iLet App on the user's phone.[1]

What the 510(k) summary says about the hardware

Here's what we found in the comparison table. The Mint cartridge holds up to 200 units of insulin and is labeled for 3 days of use plus a 12-hour grace period, while the reusable Mint controller has a two-year useful life.[1] The phone app runs on Android or iPhone.[1]

No clinical study was required. The FDA accepted bench testing of insulin delivery and a human factors study, in which people used the system in simulated conditions.[1] The FDA also cleared a Predetermined Change Control Plan, which lets the company make certain planned changes without a new 510(k).[1] The plan covers labeling for additional insulins and a new patch material.[1]

What is not cleared yet

The same September 14 release introduced 3D Intelligence, a next-generation dosing algorithm with three selectable settings that Beta Bionics had submitted to the FDA in its own 510(k).[2] The company said the devices that would run it, Mint 3D and iLet 3D, are investigational, are not available for sale and remain subject to FDA clearance.[2] Some features in the release, such as the list of compatible sensors (Dexcom G7, Dexcom G7 15 Day and FreeStyle Libre 3 Plus), were listed under Mint 3D, so we have not treated them as part of this clearance.[2]

Launch timing

Beta Bionics said it expected to begin the full commercial launch of Mint in the United States in the first quarter of 2027.[2] The company said Mint would be sold only through pharmacies, and that it expected about 40% of insured US lives to be able to buy it with their pharmacy benefit at first.[2]

What this means for you

Mint was not yet in full commercial release when this post was written; Beta Bionics gave the first quarter of 2027 as its target.[2] The cleared pump requires a prescription and is for people 6 and older.[1] Mint 3D and the 3D Intelligence algorithm had not been cleared, according to the company.[2] If you are thinking about a patch pump or a change from your current pump, talk to your care team or pharmacist.

We will add a dated update when Beta Bionics announces the launch or an FDA decision on 3D Intelligence.